A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR

A61M25/00—Catheters; Hollow probes

A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type

A—HUMAN NECESSITIES

A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE

A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR

Abstract

Provided is a guide wire, which comprises a lengthy wire body, and a marker disposed in at least the tip side portion of the wire body all over the circumference and having a function to indicate the position of the wire body in a living body. The marker is formed into a lattice shape as a whole by causing a first filament portion and a second filament portion to intersect with each other at a plurality of portions. Moreover, the intersecting portions of the first filament portion and the second filament portion are formed in plurality in the marker. Noting a predetermined one of those intersecting portions, therefore, the predetermined intersecting portion looks, as if it moves radially of the guide wire, when the guide wire is turned on its axis. Thus, it is possible to confirm reliably that the guide wire has been turned.

Description

Guide wire

The present invention relates to a guide wire.

Gastrointestinal tract, when inserting the catheter into a living body lumen such as a blood vessel in order to induce the catheter to a target site of a living body lumen, the guide wire is used. The guide wire is used by inserting into the catheter.

Further, observation and treatment of the living lumens with an endoscope is also conducted, even a catheter inserted into the lumen of the endoscope and an endoscope for inducing the target region of the biological lumens Guide wires are used.

This guide wire, when inserting the guide wire, carried out moving operation and along its axial direction, a rotation operation around the axis. Such operations to be done while confirming visually the guide wire through X-ray fluoroscopy or under endoscopic, when the guide wire is monochromatic, in response to each operation, the guide wire is reliably displaced or to (moving) are the do not know. Therefore, the guide wire, there is one marker indicating the position or the like on its surface (mark) is provided (e.g., see Patent Document 1). Mark of the guide wire described in Patent Document 1 is to form a spiral.

However, in the guide wire described in Patent Document 1, be moved along it in the axial direction, also be rotated around the axis, each portion (patent actually visible marks forming a spiral Document 1 of Figure 3 the portions of the strip-shaped (b) hatching in is applied) is moved in one direction (e.g., toward the distal end) (change) looks like. Therefore, even when rotated about its axis by applying a torque to the guide wire, despite the intention that the rotated, the guide wire was as if the forward or backward (move) by illusion like being put away. This illusion may cause an erroneous operation with respect to the guide wire. Thus, the guide wire described in Patent Document 1, was poor in operability.

JP 2001-46508 JP

An object of the present invention is excellent in operability, particularly, when rotating the guide wire about its axis, it is possible to confirm the rotation reliably, and further, a movement that movement along the axial direction and to provide a guide wire that can reliably prevent the illusion.

To achieve the above object, the present invention is, And the wire body elongated, At least the tip side portion of the wire body, its provided over the entire circumference, and a marker having a wire indicating the position of the main body function in vivo, The marker is a guide wire in which the first linear portion and a second linear portion from each other are crossed at a plurality of points, characterized in that a shape such as to form a whole in a grid .

Thus, excellent operability, in particular, the time of rotating the guide wire about its axis, the rotation can be confirmed reliably, the further, an illusion that the motion is a movement along the axial direction it is possible to reliably prevented.

Further, in the guide wire of the present invention, the marker, when the guide wire is rotated about its axis, it has a function of confirming the rotational extracorporeally preferred.

Thus, the time of rotating the guide wire about its axis by applying a torque to the guide wire, it is possible to reliably confirm that "the guide wire is rotated" (grasp).

Further, in the guide wire of the present invention, the marker, when the guide wire is moved along its axial direction, it has a function of confirming the movement extracorporeally preferred.

Thus, when moving along the guide wire in the axial direction is pushed toward the guide wire, for example, in the distal direction, (grasp) reliably confirm that "the guide wire has been moved" it is it can.

Further, in the guide wire of the present invention, the marker, the guide wire when rotated in or about an axis to move along its axis, which identifies whether the displacement is or rotation, which is moving from the outside preferably has a function.

Accordingly, since the appearance of the marker is changed, it is worn by the actual displacement of the guide wire is reliably identify whether or rotation is moved.

Further, in the guide wire of the present invention, the first linear portion is in the form a spiral, the second linear portion is wound in a direction opposite to the winding direction of the first linear portion of the helix preferred forms a turning spiral is.

Thus, the linear portion of the first linear portion and the second is provided over the entire circumference of the respective wire body, therefore, the entire circumference marker of the grid-shaped is formed.

Further, in the guide wire of the present invention, the pitch of the first linear portion of the helix, the same or different is preferably the pitch of the second linear portion of the spiral.

If the first linear portion of the helical pitch and the pitch of the helix of the second linear portion are the same, the first linear portion in a region of the marker and the second linear portion a plurality of intersections which crossed is suitably dispersed, thus improving the visibility for each intersection. Also, if the pitch of the first linear portion of the helical and the pitch of the helix of the second linear portion are different, the intersection of the first linear portion and the second linear portion intersects it can be relatively large set of formation number.

Further, in the guide wire of the present invention, the first linear portion and the second linear portions, respectively, preferably it has a portion where the pitch of the helix gradually decreased along the distal direction.

Thus, by checking the portion where the pitch is reduced gradually toward the distal end, the wire body in the portion being tapered, it is possible to grasp that easily deformable (highly flexible).

Further, in the guide wire of the present invention, the first linear portion and the second linear portions, respectively, preferably it has a portion where the width is gradually decreased along the distal direction.

Thus, a first linear portion and the second linear portion is effective when it is desired to set a relatively small size of the cross section intersecting.

Further, in the guide wire of the present invention, wherein the first linear portion and the second linear portion, the average width of one another identical or different is preferred.

If the first linear portion and the second linear portion is the average width of the same to each other, in forming the marker, it can be omitted from changing its width in accordance with each linear portion , therefore, the formation of the marker is facilitated. Further, if the average width of the first linear portion and the second linear portions to each other are different, comparing the magnitude of the cross section and the first linear portion and the second linear portion intersects target large can be set, thus improving the visibility of each intersection.

Further, in the guide wire of the present invention, the first linear portion and the second linear portions, respectively, its average width is preferably 0.5 to 2 times the average diameter of the wire body.

If the upper limit value of the numerical range, when viewing the marker, there is a case where halation occurs the intensity of light irradiated toward the marker.

Further, in the guide wire of the present invention, wherein the first linear portion and the second linear portion, color different is preferred.

For example, if the first linear portion and the second linear portion is unique to each other, when rotating the guide wire about its axis, a first linear portion and the second linear portion to each other if it is visible so as to be separated, the rotation is found in the range of one-way rotation about the axis. Further, On the contrary, if it is visually recognized as the first linear portion and the second linear portion approach each other, wherein the reverse, i.e., is a rotation in the opposite direction to the one direction It is seen that is.

The markers, the intersections of the first linear portion and the second linear portion is higher in height than other portions is preferred.

Accordingly, when inserting the guide wire lumen in the endoscope for example, guide-contacting area between the lumen of the wire and the endoscope is reduced, the improved frictional resistance (sliding resistance) sliding resistance is reduced and the operability of the guide wire is improved.

The line in the guide wire of the present invention, the first linear portion and the second linear portion, which one of these linear portions formed in advance than the other, which is the form preferably one formed as a part of the other linear portion overlying Jo unit.

This makes it possible to cross-section and the first linear portion and the second linear portion intersect are raised to form a grid-like marker with cross section which is such bumps easily and reliably.

Further, in the guide wire of the present invention, the first linear portion and the second linear portions, respectively, the liquid material was applied to the wire body, and is formed by drying preference is.

Thus, it is possible to lattice-shaped marker formed easily and reliably.

Further, in the guide wire of the present invention, at least part of the portion where the marker is disposed in the wire body is preferably a tapered shape whose outer diameter gradually decreases toward the distal end.

Thus, a relatively flexible high portion of the guide wire (wire body), i.e., becomes the marker is placed in prone portion to deform, thus, when this portion is curved (deformed), the degree of curvature it is possible to reliably confirm.

Further, in the guide wire of the present invention, the marker is formed on the outer peripheral side of the wire body, Between the wire body and the marker, the intermediate layer is formed is preferable.

This makes it possible to reliably visually recognize the marker.

Further, in the guide wire of the present invention, covering the marker and the intermediate layer preferably comprises a coating layer having a transparency enough to be visible said marker.

This makes it possible to reliably visually recognize the marker.

Further, in the guide wire of the present invention, a coil covering the distal end portion of the wire body, The marker is preferably located on the base end side than the coil.

Thus, it is possible to prevent positional interference between the coil and the marker, the structure of the guidewire is simplified.

Figure 1 is a partial longitudinal sectional view showing a first embodiment of the guide wire of the present invention. Figure 2 is a longitudinal sectional view of a region surrounded by one-dot chain line [A] in FIG. Figure 3 is a perspective view of a marker in the guide wire shown in FIG. Figure 4 is a sectional view taken along line B-B in FIG. Figure 5 is a diagram illustrating a change process of the marker when rotating the guide wire shown in Figure 1 about its axis. Figure 6 is a diagram illustrating a change process of the marker when moving along the guide wire shown in Figure 1 in its axial direction. Figure 7 is a side view showing a second embodiment of the guide wire of the present invention. Figure 8 is a side view showing a third embodiment of the guide wire of the present invention.

It will be described in detail with reference to the preferred embodiment showing a guidewire of the present invention in the accompanying drawings.

<First Embodiment> 1, guide partial longitudinal sectional view showing a first embodiment of a wire of the present invention, FIG. 2 is a longitudinal sectional view of a region surrounded by the one-dot chain line in FIG. 1 [A], FIG. 3, FIG. 1 perspective view of a marker in the guide wire shown in FIG. 4, 3 in sectional view taken along line B-B of figure 5, the marker sequence of changes when rotating the guide wire shown in Figure 1 about its axis Fig, 6 illustrating illustrates a marker process of change when moving along the guide wire shown in Figure 1 in its axial direction. In the following, for convenience of explanation, FIG. 1, FIG. 2, in FIGS. 5 and 6 right to "proximal end" (Figure 7, Figure 8 as well), refers to the left side as "distal end". Further, in FIG. 1, for ease of understanding, and reduce the length direction of the guide wire, an exaggerated thickness direction of the guide wire is shown schematically, in the longitudinal direction and thickness direction the ratio is different from the actual.

Guide wire 1 shown in FIG. 1 is constituted by a catheter guide wire used to insert into the lumen of the catheter (including an endoscope), a core wire having flexibility or softness (wire) 3 and the wire body 2, a spiral coil 4, a resin coating layer 6, an annular member (step filling member) 5, and a marker 12.

In this embodiment, the wire body 2 is composed of a continuous core wire 3 of the elongated one, the cross-sectional shape of the core wire 3 has a circular shape. However, the present invention is not limited thereto, the core wire 3 may be the same or different plurality of core wire material (wires) may be obtained by joining (connecting), such as by welding brazing contact the like. Incidentally, the core wire 3, for example, if is obtained by joining two core wires, the joint portion includes a body portion 32 to be described later, a tapered portion 34, and located in any of the small-diameter portion 36 it may be.

Length of the guide wire 1 is not particularly limited, is preferably about 200 ~ 5000 mm. The outer diameter of the guide wire 1 (average) is not particularly limited, is preferably about 0.2 ~ 1.2 mm.

The core wire 3 extends over substantially the entire length of the guide wire 1, a body portion 32 corresponding to the body portion of the guide wire 1, the tapered portion (outer diameter gradually reducing unit) 34 located on the distal side, the tip It is composed of a small diameter portion 36 located on the side. Body portion 32 is an outer diameter substantially constant, the tapered portion 34 is gradually decreased its outer diameter toward the distal direction (has a tapered), the small diameter portion 36 has an outer diameter of approximately It is constant.

By providing the tapered portion 34 to the core wire 3, (in continuous) flexibility of the core wire 3 toward the vicinity of the boundary between the main body portion 32 and the tapered portion 34 in the distal direction gradually increases, as a result, the guide wire since 1 flexibility increase, thereby improving the operability and safety when inserted into the living body.

Over the proximal end side from the middle of the tapered portion 34, the marker 12 is formed (see FIG. 1). Thus, a relatively flexible high portion of the guide wire 1 (wire body 2), i.e., becomes the marker 12 is disposed to easily portion to deform, thus, when this portion is curved (deformed), the the degree of curvature can be confirmed reliably.

Further, by having a small-diameter portion 36 on the distal end side of the tapered portion 34, the flexible portion of the cutting edge can be prolonged, the effect of the cutting edge portion becomes more flexible occur.

Further, at least a portion of the small diameter portion 36 of the core wire 3 may be a reshapable (shaping) can reshaped portion. The shape of the reshaping unit, flat or prismatic, etc. are preferable.

The outer diameter of the main body portion 32 of the core wire 3 is not particularly limited, but is preferably in the order of 0.3 ~ 1.0 mm, more preferably about 0.4 ~ 0.7 mm.

The outer diameter of the small-diameter portion 36 of the core wire 3 is not particularly limited, but is preferably in the order of 0.05 ~ 0.3 mm, more preferably about 0.1 ~ 0.2 mm. The outer diameter of the small diameter portion 36 is not limited to be constant may be one having an outer diameter gradually decreases toward the distal end.

The length of the tapered portion 34 is different variety on the application or kind of the guide wire 1, but are not particularly limited, preferably about 10 ~ 300 mm, more preferably may be about 30 ~ 250 mm.

The length of the small diameter portion 36 is not particularly limited, preferably about 0 ~ 100 mm, more preferably may be about 10 ~ 50 mm.

Incidentally, the taper angle (the reduction ratio of the outer diameter) of the tapered portion 34 may be constant along the longitudinal direction of the core wire 3 (wire body 2), also, there may be sites that varies along the longitudinal direction. Further, the tapered portion 34 is not limited to one place, it may be provided in two or more places.

Examples of the material of the core wire 3, for example, stainless steel, Ni-Ti-based alloy, Ni-Al based alloy, and various metallic materials such as superelastic alloys such as Cu-Zn-based alloy, a relatively high rigidity of the resin material and the like, can be used singly or in combination of two or more of them.

Further, the outer periphery of the distal end portion of the core wire 3 (wire body 2), i.e., in the illustrated arrangement, the outer periphery to the middle of the outer and the tapered portion 34 of the small diameter portion 36 of the core wire 3, the coil 4 is disposed. The coil 4 is a member formed by strands (thin line) winding (wire) spirally (formation), it is disposed so as to cover the distal end portion of the core wire 3 (wire body 2) (outer periphery) ing. In the illustrated arrangement, the tip end portion of the core wire 3 (tip) is inserted through the substantially central portion of the inner coil 4. The tip-side portion of the core wire 3 is inserted in the inner surface of the coil 4 and the non-contact.

The proximal end of the coil 4 is located in the middle of the tapered portion 34 of the core wire 3, the base end side thereof, the marker 12 is located. Thus, it is possible to prevent positional interference between the coil 4 and the marker 12, the structure of the guide wire 1 is simplified. Incidentally, the marker 12 may be formed to the outer peripheral side of the coil 4, i.e., it may be formed so as to overlap with the coil 4 in side view.

In the illustrated arrangement, the coil 4, while no external force is applied, while it is empty space between the wires mutually wound helically, unlike shown, no external force is applied, the helix wound strands themselves may be densely arranged without a gap to Jo.

Coil 4 is preferably made of a metal material. The metallic material constituting the coil 4 include stainless steel, superelastic alloys, cobalt based alloys and gold, platinum, noble metals or alloys thereof such as tungsten (eg, platinum - iridium alloy) and the like. In particular, when configured with X-ray opaque material such as a noble metal (material having an X-ray contrast property) is, X-ray contrast property can be obtained in the guide wire 1, check the position of the tip under X-ray fluoroscopy It can be inserted into a living body while preferred. The coil 4 may be configured and its distal side and proximal end side of different materials. For example, the coils of the X-ray opaque material tip side may be each composed of a coil of material relatively transparent to X-rays a base end side (such as stainless steel). Note that the total length of the coil 4 is not particularly limited, is preferably about 5 ~ 500 mm. Further, in this embodiment, the coil 4 is cross section of the strand is used as a circular, not limited to this cross section, for example elliptical wire, square (in particular rectangular) thing such as it may be.

Proximal and distal ends of the coil 4 are respectively secured to the core wire 3 (fixed) by a fixing material 81 and 82.

These fixing material 81 and 82, i.e., the two fixing portions for fixing the core wire 3 and the coil 4 is provided on the distal side of the annular member 5 to be described later, not in contact with the annular member 5. This makes it possible to the core wire 3 and the annular member 5 through the fixing material 81 is prevented from conducting, this makes it possible to the outer surface and the core wire 3 of the guide wire is prevented from conducting.

Fixing material 81 and 82 are each composed of solder (brazing material). The fixing materials 81 and 82, respectively, is not limited to solder, for example, may be an adhesive. Further, the method of fixing the coil 4 is not limited to by a fixing material, for example, it may be welded.

The guide wire 1 has the distal end portion of the core wire 3 (wire body 2), the coil 4, a resin coating layer 6 covering the outer periphery (outer surface) of the fixing material 81 and 82. The resin coating layer 6 is in close contact with the outer periphery of the distal end portion of the core wire 3.

In the illustrated arrangement, the resin coating layer 6 is intrudes in the coil 4, it may not penetrate into the coil 4.

Resin coating layer 6 can be formed for various purposes, as an example, the guide wire 1 improvement in safety when inserted into the blood vessel or the like can be provided for the purpose. For this purpose, the resin coating layer 6 is highly flexible material (a soft material, an elastic material) that is composed of a preferred. As the material, such as polyethylene, polyolefins such as polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, silicone resins, polyurethane elastomers, polyester elastomers, thermoplastic elastomers such as polyamide elastomer , latex rubber, various rubber materials such as silicone rubber or a composite material of a combination of two or more of these may be mentioned.

In particular, when the resin coating layer 6 is those composed of thermoplastic elastomers and various rubber materials described above, the flexibility of the distal portion of the guidewire 1 is improved, upon insertion into a blood vessel or the like, a blood vessel it is possible to more reliably prevent damaging the inner wall, an extremely high safety.

Further, in the resin coating layer 6, X-ray opaque material (X-ray material having a contrast property) configuration particles (filler) may be dispersed. Thus, the guide X-ray contrast properties to the wire 1 is obtained, can be inserted into a living body while confirming the position of the tip under X-ray fluoroscopy. As the material of the particles is not particularly limited as long as the X-ray opaque material, e.g., gold, platinum, noble metals or alloys thereof such as tungsten (eg, platinum - iridium alloy) can be used.

The thickness of the resin coating layer 6 is not particularly limited, formed object or material constituting the resin coating layer 6 is suitably in consideration of the formation method and the like, usually it has a thickness (average), 30 - it is preferably about 300 [mu] m, more preferably about 50 ~ 200 [mu] m. If the thickness of the resin coating layer 6 is too thin, it may form an object of the resin coating layer 6 is not sufficiently exhibited. If the thickness of the resin coating layer 6 is too thick, which may affect the physical properties of the wire body 2 (guide wire 1). Incidentally, the resin coating layer 6 may be a laminate of two or more layers.

The end surface of the resin coating layer 6 is rounded. Thus, the guide upon insertion of the wire 1 into a blood vessel or the like, it is possible to more reliably prevent damaging the blood vessel inner wall at the distal end surface of the resin coating layer 6 (guide wire 1).

Guide wire 1, the base end of the resin coating layer 6 has an annular member 5 provided so as to fill the step space between the proximal end and the wire body 2 of the resin coating layer 6. The outer diameter of the proximal end of the resin coating layer 6 is larger than the outer diameter of the wire body 2 at the proximal end of the resin coating layer 6, the step space is caused by the difference of these outer diameters.

The outer diameter of the distal end 52 of the annular member 5 is approximately equal to the outer diameter of the proximal end of the resin coating layer 6, the base end face 61 of the resin coating layer 6, the distal end surface 53 of the annular member 5 is joined (adhesion) ing. In this case, the resin coating layer 6, beyond the tip 52 of the annular member 5 to the proximal end side, so as not incurring the annular member 5. That is, between the base end of the tip 52 and the resin coating layer 6 of the annular member 5, to form a continuous surface without steps.

The outer diameter of the annular member 5, towards the proximal side from the distal end side (toward the proximal direction) is gradually decreased, the outer diameter of the proximal end 51 of the annular member 5, than the outer diameter of the distal end 52 small. The outer diameter of the proximal end 51 of the annular member 5 is substantially equal to the outer diameter of the wire body 2 (coating layer 7) at the proximal end 51 of the annular member 5. That is, between the wire body 2 (coating layer 7) and the proximal end 51 of the annular member 5, to form a continuous surface without steps. The outer diameter of the proximal end 51 of the annular member 5 is smaller than the outer diameter of the body portion 32 of the core wire 3. The annular member 5 has a length of 0.5 ~ 15 mm.

The inner diameter of the proximal end 51 of the annular member 5 is larger than the inner diameter of the tip 52. As will be described later, the annular member 5 so as to make a located the tapered portion 34 of the core wire 3. Incidentally, the inner diameter of the proximal end 51 may be the same as the inner diameter of the tip 52.

The annular member 5, the proximal end portion of the resin coating layer 6 can be prevented from being caught by the medical device of elevator etc. front end and the endoscope catheter used in combination with the guide wire 1, This allows the resin coating layer 6 is prevented Shimano peeled. Further, it is possible to prevent the deterioration of slidability of the guide wire 1 according to the step.

The inclination angle of the annular member 5 theta (taper angle) (rate of decrease in outer diameter), in this embodiment, is constant along the longitudinal direction of the core wire 3 (wire body 2). The inclination angle θ, there may be a portion that varies along the longitudinal direction. The inclination angle theta, preferably at 30 ° or less, more preferably about 2 ~ 25 °, and further preferably about 5 ~ 20 °. Thus, the annular member 5 can be prevented from being caught by the medical instrument raiser such a catheter tip and an endoscope used in combination with the guide wire 1.

The hardness (hardness) of the annular member 5 is preferably set to be higher than the hardness of the resin coating layer 6. Thus, the annular member 5 can be prevented from being caught by the medical instrument raiser such a catheter tip and an endoscope used in combination with the guide wire 1.

Moreover, either or both of the inner peripheral surface and the distal end face 53 of the annular member 5 may be roughened. Adhesion of the distal end face 53 of the annular member 5 is roughened to improve adhesion between the resin coating layer 6, also when the inner peripheral surface is roughened, the fixing material 9 to be described later sex can be improved.

Also, the material for the annular member 5 is not particularly limited, for example, may be used various resin materials, various metallic materials and the like. For example, it is also possible to use the same constituent material and the resin coating layer 6, can also be used different constituent materials and the resin coating layer 6.

However, the annular member 5 is preferably made of a metal material (metal) or a hard resin material (resin), particularly preferably composed of a metal material. As the metal material constituting the annular member 5, for example, it may be used stainless steel, titanium, titanium alloys, Ni-Ti alloy, aluminum, gold, platinum and the like. Precious metals such as gold and platinum, or X-ray contrast is improved by forming at its alloys. Also, when constituting the annular member 5 of metal material, it may be covered with a coating layer (not shown) the outer periphery of the annular member 5. The constituent material of the coating layer is not particularly limited, for example, various resin materials, various ceramics, can be used various metallic materials such as, in particular, to use an insulating material preferred. Also, when constituting the annular member 5 in a hard resin material, as the material thereof, for example, it may be used polycarbonate, polyamide (nylon), polyethylene terephthalate, polyacetal, polyphenylene sulfide and the like.

The annular member 5, the fixing material 9 provided on the outer periphery of the core wire 3 (wire body 2) is fixed to the core wire 3 (wire body 2) (fixed).

Fixing material 9 is constituted by an adhesive, particularly preferably composed of an insulating adhesive. Thus, it is possible to insulate the core wire 3 and the annular member 5, whereby, for example, when placing along the medical device to be used by passing an electric current to the guidewire 1, leakage from the outer surface of the annular member 5 it is possible to prevent the like.

Incidentally, the fixing material 9 is not limited to adhesives, for example, when configuring the annular member 5 of a metal material, or a solder (brazing material) or the like. Further, the method of fixing the annular member 5 is not limited to those with a fixed material, of course.

The annular member 5 is located the tapered portion 34 of the core wire 3 (wire body 2). In the illustrated arrangement, all of the annular member 5 (the total), but are located in the tapered portion 34 is not limited to this, only a part of the annular member 5 may be positioned in the tapered portion 34.

The annular member 5 has rigid with the proximal side of the annular member 5 of the wire body 2 and the front end side (bending rigidity, torsional rigidity) of the function of reducing the difference. That is, as described above, the tapered portion 34 of the core wire 3, and then gradually decreases its outer diameter toward the distal direction, rigidity day become lower toward the distal direction. On the other hand, the distal end side of the annular member 5 of the wire body 2, and the resin coating layer 6 is provided, if the annular member 5 is not provided, at the proximal end of the resin coating layer 6, the rigidity rapidly increased, kink (bending) likely to occur. However, in the guide wire 1, the annular member 5, an abrupt increase in rigidity at the proximal end of the resin coating layer 6 is prevented, thereby preventing kinking at the proximal end of the resin coating layer 6.

Now, in the present invention, the guide wire 1, except that used under X-ray fluoroscopy, for example, those used through an endoscope, and more particularly, a catheter inserted into the lumen of an endoscope vivo guide wire (hereinafter, referred to as "via endoscopic guide wire") used to induce the target region of the tube 腔等 can be applied to. Hereinafter, in the present embodiment, typically, the case of applying the guide wire 1 to Keinai endoscope guide wire.

The through endoscopic guide wire, the outer surface of the guide wire 1, the guide wire 1 (wire body 2) a visual marker has a function of indicating the position of the in vivo provided, its visual marker through the endoscope viewing the. In the present embodiment, which corresponds to the viewing marker is marker 12. The marker 12 is the base layer (intermediate layer) 13 through, are provided on the outer periphery of the wire body 2 (see FIG. 2). Further, the guide wire 1, the coating layer 7 covering the marker 12 and the base layer is also provided (see FIG. 2).

As shown in FIG. 1, the marker 12 is composed of a first linear portion 121 and the second linear portion 122.

First linear portion 121 is obtained by spirally winding. Accordingly, the first linear portion 121 is provided over the entire circumference of the wire body 2. The first linear portion 121 is adapted to open coiled a line with adjacent spaced.

Second linear portion 122 is formed into a similar spiral in the first linear portion 121, the winding direction, the winding direction of the spiral of the first linear portion 121 and the opposite direction going on. Thus, the second linear portion 122 is provided over the entire circumference of the wire body 2. The second linear portion 122, like the first linear portion 121, and is open coiled a line with adjacent spaced.

By the first linear portion 121 and the second linear portion 122 is formed in this manner, it is that these linear portions intersect at a plurality of points to each other, thus, the marker 12, overall shape of the one forming a grid pattern.

Incidentally, as shown in FIG. 2, the first linear portion 121 and the second linear portion 122, respectively, and raised from the base layer 13, longitudinal sectional shape that is intended to form a semi-oval , its top is convexly curved. The height of the first linear portion 121 and the second linear portion 122 is not particularly limited, for example, is preferably from 3 ~ 8 [mu] m, and more preferably 3 ~ 5 [mu] m.

The guide wire 1 when observed through the endoscope from outside the body, the marker 12 is observed in the state as shown in FIGS. 5 and 6. With reference to FIG. 5, and described as being rotated the guide wire 1 about its axis, with reference to FIG. 6, the case has moved along the guide wire 1 in its axial direction.

First, a description will be given of a case of rotating the guide wire 1 about its axis. 5 (a) shows the state before rotating the guide wire 1. When the guide wire 1 by a predetermined amount (angle) rotated in the arrow direction in the drawing, the state shown in Figure 5 (b).

As described above, the marker 12, intersections of the first linear portion 121 and the second linear portion 122 intersect (intersection) 123 is formed with a plurality (see Fig. 1). Here, actually can be observed (in FIG. 5 (a)) the first linear portion 121 and the intersection portion 123a of the second linear portion 122, 123b, 123c, 123d, the 123e and 123f focusing, these intersections 123a ~ 123f are in FIG. 5 (b), has moved downwards in the figure than the state of FIG. 5 (a).

By being able to thus visually recognize the marker 12, when the over torque the guide wire 1 is rotated the guide wire 1 about its axis, reliably confirmed that "the guide wire 1 is rotated" to (understand) can be.

Further, the guide wire 1 wherein is rotated in the opposite direction, intersecting portions 123a ~ 123f moves toward upward in the drawing than the state of FIG. 5 (a). Thus, whether the guide wire 1 is rotated in either direction, i.e., it is possible to confirm the rotation direction of the guide wire 1.

Next, a description will be given when moving along the guide wire 1 in its axial direction. 6 (a) shows a state before moving the guide wire 1. The guide predetermined amount wire 1 to the direction of the arrow in FIG. Once (distance) is moved, a state shown in Figure 6 (b).

Here, the fact can be observed (in FIG. 6 (a)) is focused on intersections 123a ~ 123f of the first linear portion 121 and the second linear portion 122, these intersections 123a ~ 123f is in FIG. 6 (b), has moved toward the distal end (left in the figure) than the state in FIG. 6 (a). Further, intersection portions 123a and 123b are disengaged from the viewing angle (viewing area) (disappears).

By being able to thus visually recognize the marker 12, when moving along the guide wire 1 in the axial direction is pushed toward the guide wire 1 in the distal direction, referred to as "guide wire 1 is moved" it is possible to reliably confirmed (to know) that.

Also, moving in the opposite direction to the pull the guide wire 1, intersections 123a ~ 123f are moved toward the proximal end direction from the state of FIG. 6 (a) (the right side in the drawing). Thus, whether the guide wire 1 is moving toward the either direction, i.e., it can be confirmed the direction of movement of the guide wire 1.

As described above, in the guide wire 1, when rotating the guide wire 1 into or around the axis moving along its axis, by the above-described change of the marker 12, the actual displacement of the guide wire 1 is in the mobile it is wear to reliably identify whether the certain or rotation.

Further, unintentionally as a guidewire having a marker that forms the conventional single spiral like, even when rotated about its axis by applying a torque to the guide wire was the rotation, the guide wire There would be an illusion as if advanced or set back there (moving to). For example, stripes of red and blue in sign pole of the barber shop, but in fact it is only being rotated, nevertheless, the same phenomenon as the seem to move up to the top if it was it is. However, the guide wire 1, it is possible to prevent such illusion (trouble) reliably, and excellent operability.

As shown in FIG. 1, the same position in the axial direction of the wire body 2, i.e., the wire in the body portion 32 and the tapered portion 34 of the body 2, pitch and like the second line of the helix of the first linear portion 121 the pitch of the helical parts 122, are the same size. Thus, a plurality of intersections 123 in the formation region of the marker 12 is suitably dispersed, thus improving the visibility for each intersection 123. Further, there is an advantage that the rotation of the guide wire 1, pushing and pulling the guide wire 1 (movement) and that there is to distinguish the easier.

Further, the marker 12, and the pitch reduction unit 124 the pitch of each helix of the first linear portion 121 and the second linear portion 122 at the tapered portion 34 gradually decreases toward the tip end direction is formed there. By confirming the pitch reduction unit 124 has become thinner wire body 2 in the portion, it is possible to grasp that easily deformable (highly flexible).

Figure 1 As shown in (FIG. 5, FIG. 6 as well), the width of the first linear portion 121 (average), and the width of the second linear portion 122 (average), becomes the same size ing. Thus, in forming the marker 12 can be omitted from changing its width in accordance with each linear portion. Therefore, formation of the marker 12 is facilitated.

The first linear portion 121 and the second linear portion 122, respectively, is preferably the width is 0.5 to 2 times the average diameter of the wire body 2, 0.5 to 1.5 and more preferably in the range of times. If the upper limit value of the numerical range, when viewing the marker 12, which may halation occurs the intensity of light irradiated from the endoscope.

Further, the first linear portion 121 and the second linear portion 122, even color same as each other or may be different, especially preferably are different. If the first linear portion 121 and the second linear portion 122 are unique to each other, when rotating the guide wire 1 about its axis, a first linear portion 121 and the second linear portion if it is visually recognized as 122 and are separated from each other, the rotation is found in the range of rotation of the direction of the arrow in FIG. Further, On the contrary, if it is visually recognized as the first linear portion 121 and the second linear portion 122 approach each other, contrary to the above, i.e., opposite to the arrow direction in FIG. 5 it can be seen that a rotation direction.

As shown in FIG. 3, the marker 12, the height of the intersection 123, other portions, i.e., the portion of the high excluding the intersection 123 of the first linear portion 121 and the second linear portion 122 It is higher than that of. The height of the intersection 123 is not particularly limited, for example, is preferably from 3 ~ 10 [mu] m, and more preferably 5 ~ 8 [mu] m.

As described above, the marker 12 is covered with a covering layer 7. The coating layer 7 has at its outer surface (the outer surface of the guide wire 1), site of intersection 123 (marker 12) are arranged, the first linear portion 121 and the second linear portion 122 is disposed It raised against site being. Namely, as shown in FIG. 4, the site of intersection 123 is located, the raised portion (the portion is raised) (convex portion) 71 is formed, is disposed only the second linear portion 122 the site recess (recessed portion) (recess) 72 is formed. Shape which is the thickness of the covering layer 7 is relatively thin, the outer surface of the coating layer 7, which under the influence of the intersection 123, which the corresponding to the shape and pattern of the intersecting portion 123 is raised (corresponding to become) is for. Further, the coating layer 7, guide the outer surface of the wire 1, raised against sites sites intersection 123 is disposed, the first linear portion 121 and the second linear portion 122 is not arranged to. That is, the site where intersections 123 are disposed, raised portion 71 is formed, at a portion where the first linear portion 121 and the second linear portion 122 is not arranged, is recessed portion 72 is formed . Sites first linear portion 121 and the second linear portion 122 is not disposed, than to the region where the first linear portion 121 and the second linear portion 122 is disposed, intersection 123 There is recessed with respect to arranged site.

Thus, sites intersection 123 is arranged, scattered on the outer surface of the guide wire 1. If the raised portion is spiral, whereas a line contact with the lumen of the lumen and an endoscope catheter, the raised portions which intersection 123 is disposed, since it is in point contact with the lumen such as an outer surface of the coating layer 7, the contact area between the lumen of the lumen and an endoscope catheter is reduced, the frictional resistance (sliding resistance) is improved slidability is reduced, the operation of the guide wire 1 sex becomes good.

Further, the raised portion 71 and the recess 72 is not intended to be formed by processing a coated layer 7 directly, since it is formed under the influence of the intersection 123 immediately below the cover layer 7, the outer covering layer 7 sharp corners and the top, etc. is not formed on the surface, its outer surface is smooth. That is, the raised portion 71, following the rounded top of the first linear portion 121 and the second linear portion 122, carry the same roundness as this. This further improves Suridosei, also very high safety.

First linear portion 121 and the second linear portion 122 are each formed of a material containing resin and pigment. The constituent material and the material of the second linear portion 122 of the first linear portion 121, are substantially the same, or less, representatively described constituent material of the first linear portion 121.

Color of the first linear portion 121 is mainly on the type and characteristics of the pigment contained in the first linear portion 121, the composition and characteristics of the resin material (in particular, color tone, etc.), by the content of the pigment determined by adjusting them, thereby making it possible to freely set.

Here, to recognize the movement of the guide wire 1 through an endoscope, the color of the first linear portion 121 is one of the key elements, which has a base color layer 13 serving as a base consideration should be given to the combination of.

As an example, the base layer 13, silver white (metallic color), a gray or black color, the first linear portion 121, when red or yellow, the difference in brightness between the two colors large (high contrast) , thereby, the visibility of the first linear portion 121 is high, preferred. Similarly, when in the color of both eg complementary colors, the visibility of the first linear portion 121 is high, preferred. Further, for example, black or dark color (charcoal gray, dark brown, dark blue, purple, etc.) with respect to yellow, yellow-green, and orange or the like against blue, red, orange, pink or the like, a clear contrast it is particularly preferred to select a combination that express. Also, similar colors that shade different, for example, dark blue and light blue, may be russet and pink.

The resin contained in the material constituting the first linear portion 121 is not particularly limited, and is preferably the following (1) or (2).

(1) The resin contained in the material constituting the first linear portion 121, it is preferable to use a melting point of 200 ° C. or more resins (heat-resistant resin), that the melting point used 200 ~ 300 ° C. of about Resin more preferable.

The melting point of 200 ° C. or more resins, for example, polysulfone, polyimide, polyether ether ketone, polyarylene ketone, polyphenylene sulfide, polyallylate sulfide, polyamideimide, polyetherimide, polyimide sulfone, polyaryl sulfone, polyallyl polyethersulfone, polyesters, polyether sulfone and polytetrafluoroethylene (PTFE), ethylene - tetrafluoroethylene copolymer (ETFE) and a fluorine-based resin and the like, and one or more of these in combination it can be used.

(2) The resin contained in the material constituting the first linear portion 121, it is preferable to use a thermosetting resin.

As the thermosetting resin, for example, epoxy resin, phenol resin, polyester (unsaturated polyester), polyimide, silicone resin, polyurethane, and the like, can be used singly or in combination of two or more of these .

The content of the pigment in the first linear portion 121, pigment type and characteristics, depending on the composition and characteristics of the resin material, in order to obtain a good color, the first linear portion 121 whole hand, is preferably about 10 to 99 wt%, more preferably about 20 to 50 wt%.

The pigment in the first linear portion 121 is preferable to be uniformly dispersed, or may be localized in example outer surface side of the first linear portion 121. The pigment, inorganic pigments may be either organic pigments, preferably in terms of heat resistance are inorganic pigments. Examples of the inorganic pigments, carbon black, mica, titanium dioxide, titanium yellow, Prussian blue, Miroriburu, cobalt blue, ultramarine, Viridian like can be used. Incidentally, the pigment may be used alone, in combination of two or more may be (in particular mixture) it was. The average particle size of the pigment is not particularly limited, for example, is preferably from 0.3 ~ 5 [mu] m, and more preferably 0.5 ~ 3 [mu] m.

Such markers 12 may be formed as described below. Of the first linear portion 121 and the second linear portion 122 is formed by a first linear portion 121 is also preceded the second linear portion 122.

To form the first linear portion 121, first, with respect to the core wire 3 to be the wire body 2, the portion excluding the region for forming the first linear portion 121, a masking tape helically wound Turn and paste.

Then, the masking tape of the core wire 3 is not wound, to the exposed portion, (grant) applying the liquid resin material in which the pigment is added (hereinafter referred to as "liquid material"). As the coating method, for example, a method, and the like by the method and dipping using a spray.

By this process, it is possible to form the first linear portion 121. Next, a second linear portion 122.

To form the second linear portion 122, first, with respect to the core wire 3 which first linear portion 121 is formed in a portion excluding the region for forming the second linear portion 122, a masking the said tape pasting wound helically in opposite directions.

Then, as well as to form a first linear portion 121, the masking tape of the core wire 3 is not wound, applying a liquid material to the exposed portion.

By this process, it is possible to form the second linear portion 122 which partially overlies the first linear portion 121. Therefore, it is possible to intersections 123 to form easily and surely the lattice marker 12 was raised.

The first linear portion 121 and the second linear portion 122, respectively, may be formed one by one, or may be formed are provided in plurality. Also, their number formation may be the same or may be different.

Further, the first linear portion 121 and the second linear portion 122, but to each other the width in the configuration shown in FIG. 1 are the same is not limited thereto and may be different widths from each other.

Figure 2, as will shown in FIG. 4, the coating layer 7 covering the marker 12 and the underlying layer 13 is formed. The coating layer 7 has a transparency enough to be visible marker 12.

Coating layer 7 can be formed for various purposes, improving as an example, to reduce friction between the guide wire 1 (sliding resistance), the operability of the guide wire 1 by improving the slidability there be.

To reduce the friction of the guide wire 1 (sliding resistance), the coating layer 7 is preferably formed of a material capable of reducing friction as described below. Thus, guide the frictional resistance of the inner wall of the catheter used together with the wire 1 (sliding resistance) is improved slidability is reduced, the operability of the guide wire 1 in the catheter or endoscope is better ones to become. Further, since the sliding resistance of the guide wire 1 is lowered, the endoscope guide wire 1 when the moved and / or rotated within (the same applies to the catheter), the guide wire 1 of the kink (bending) or torsion it can be more reliably prevented.

Further, the coating layer 7, preferably made of an insulating material. Since the reason, the tip portion of the covering layer 7 is located, the annular member 5 to the outer periphery of the coating layer 7 enters into the annular member 5, by forming the coating layer 7 with an insulating material, the core wire 3 and the annular member 5 bet it is possible to insulate. Thus, for example, when placing along the medical device to be used by passing an electric current to the guidewire 1 can be prevented leakage or the like from the outer surface of the annular member 5.

Among them, in the case of using a fluorine-based resin (or a composite material containing the same) can reduce the frictional resistance between the guide wire 1 and the inner wall of the catheter (sliding resistance) more effectively, the slidability can be improved, operability of the guide wire 1 in the catheter becomes more favorable. This also, when you move and / or rotate the guide wire 1 in the endoscope, it is possible to more reliably prevent the guide kinking of the wire 1 (bending) or torsion.

The average thickness of the coating layer 7 is not particularly limited, for example, is preferably from 10 ~ 40 [mu] m, and more preferably 20 ~ 30 [mu] m.

Figure 2, as shown in FIG. 4, between the marker 12 and the wire body 2, the color of the underlying layer 13 different from the marker 12 is formed. The constituent material of the underlying layer 13 is not particularly limited, for example, can be the same as the coating layer 7. For example, in the case of using a fluorine-based resin (or a composite material containing the same) into the material of the underlying layer 13, baking, by a method such as spraying, while heating the resin material, the coating of the core wire 3 it can be carried out. Thus, adhesion between the core wire 3 and the underlying layer 13 is particularly excellent. Then, through the underlying layer 13, the marker 12 and the coating layer 7 is fixed to the core wire 3.

The average thickness of the base layer 13 is not particularly limited, for example, is preferably from 3 ~ 20 [mu] m, and more preferably 5 ~ 10 [mu] m.

Note that the outer surface of at least the tip portion of the guide wire 1, preferably hydrophilic material is coated. This causes a lubricious hydrophilic material is wetted, the reduced friction of the guide wire 1 (sliding resistance) is Suridosei is further improved. Therefore, the operability of the guide wire 1 is further improved.

Such hydrophilic materials are often exhibit lubricity by wetting (water absorption), the frictional resistance between the inner wall of the catheter (tube) or an endoscope used together with the guide wire 1 (sliding resistance) reduction to. Accordingly, slide resistance is further improved in the guidewire 1, the operability of the guide wire 1 in the catheter becomes more favorable.

<Second Embodiment> Figure 7 is a side view showing a second embodiment of the guide wire of the present invention.

Hereinafter, a description of a second embodiment of the guide wire of the present invention with reference to this figure focuses on the differences from the embodiment described above, the same matters will be omitted.

This embodiment, except that the formation state of the first linear portion and the second linear portion (forming conditions) is the same as the first embodiment.

In the marker 12A of a guide wire 1A shown in FIG. 7, the pitch of the helix of the first linear portion 121 and the pitch of the helix of the second linear portion 122, and is different sizes. In the illustrated arrangement, the pitch of the helix of the second linear portion 122 is set smaller than the pitch of the helix of the first linear portion 121. Such a configuration is effective when it is desired to relatively large set of numbers forming the intersection 123.

Further, the width of the first linear portion 121 (average), and the width of the second linear portion 122 (average), and the size are different from each other. In the illustrated arrangement, the width of the first linear portion 121 is made larger (thicker) setting than the width of the second linear portion.

With this configuration, it is possible to set larger than the size of each intersection 123 in the size first embodiment of the intersections 123 of the present embodiment. This improves the visibility of the intersection 123, namely, it can be made the respective intersections 123 easier to see.

<Third Embodiment> Figure 8 is a side view showing a third embodiment of the guide wire of the present invention.

Hereinafter, a description will be given of a third embodiment of the guide wire of the present invention with reference to this figure focuses on the differences from the embodiment described above, the same matters will be omitted.

This embodiment, except that the formation state of the first linear portion and the second linear portion (forming conditions) is the same as the first embodiment.

In marker 12B of a guide wire 1B shown in FIG. 8, the width of each of the first linear portion 121 and the second linear portion 122 are gradually decreased along the distal direction. Portion where the width is gradually reduced (the width decreasing section) is preferably formed in the tapered portion 34 of the wire body 2. By confirming such moieties, has become thinner wire body 2 in the portion, it is possible to grasp that easily deformable (highly flexible).

Also, depending on the respective width of the first linear portion 121 and the second linear portion 122 are different from the size in the side view of the intersection 123. Such a configuration is effective when in accordance with the outer diameter of the wire body 2 want to change the size of each intersection 123. For example, as shown in FIG. 8, the tapered portion 34 of the wire body 2, to reduce the size of each intersection 123, the main body portion 32 outer diameter (average) is greater than the taper section 34, each intersection 123 it can be increased in size. Thus, as the intersections 123 legible.

While the guide wire of the present invention have been described embodiments illustrated in the drawings, the present invention is not limited to this, each unit constituting the guide wire may be of any configuration capable of exhibiting the same function it can be replaced with. Or it may be added with a arbitrary structures.

The guide wire of the present invention, among the respective embodiments, or may be a combination of arbitrary two or more configurations (features).

The first linear portion and the second linear portions, respectively, not limited to the liquid material formed by drying, for example, by winding a member of the strip (ribbon-like) in a spiral it may be the one.

The guidewire of the present invention includes an elongated wire body, at least on the tip side portion of the wire body, it is provided over its entire periphery, and a marker which has a function of indicating the position of said wire body in vivo , the marker has a first linear portion and a second linear portion from each other are crossed at a plurality of points, it has a shape such as to form a whole in a grid. Therefore, the marker cross section and the first linear portion and the second linear portion intersect is formed with a plurality, paying attention to a given intersection of these intersections and (observing), the guide wire when rotated about its axis, looks like the predetermined intersections are moved in the radial direction of the guide wire. By being able to thus visually recognize the marker, the time of rotating the guide wire about its axis, it is possible to reliably confirm that "the guide wire is rotated" (grasp). Also, when moving along the guide wire in the axial direction, unlike the case of rotating the guide wire about its axis, so that the predetermined intersection moves along the axial direction of the guide wire appear. Thus, in the guide wire, when rotating the guide wire or around an axis to move along its axis, because the appearance of the marker is different, or the rotation actual displacement of the guide wire is moved kill is possible to reliably identify whether it is. Therefore, when rotating the guide wire about its axis, it is possible that movement reliably to prevent movement and to illusion along the axial direction, is excellent in operability. Also, marker, if intersection of the first linear portion and the second linear portion is of a higher height than the other portions, the outer surface of the guide wire is raised at the crossing and thus. Thus, the guide wire and the outer surface, for example, the contact area between the lumen of the lumen and an endoscope catheter decreases, frictional resistance (sliding resistance) is improved slidability is reduced, guidewire operability becomes good. Thus, the guide wire of the present invention has industrial applicability.

Claims (5)

And the wire body elongated, At least the tip side portion of the wire body, its provided over the entire circumference, and a marker having a wire indicating the position of the main body function in vivo, The marker is a guidewire in which the first linear portion and a second linear portion from each other are crossed at a plurality of points, characterized in that a shape such as to form a whole in a grid.

The marker, when the guide wire is rotated about its axis, the guide wire of claim 1 having the function of confirming the rotation from outside the body.

The marker, when the guide wire is moved along its axial direction, guide wire of claim 1 having the function of confirming the movement from the outside.

The marker, when said guide wire is rotated to or about an axis to move along its axis, according to whether the displacement is or rotation, which is moving in claim 1 having a function of identifying extracorporeally guide wire.

Said first linear portion is in the form a spiral, the second linear portions, according to claim 1 forming a spiral wound said first linear portion of the winding in the winding direction opposite to the direction of the helix guidewire according to.